BRPI0707845A2 - drug sending device - Google Patents

Abstract

DRUG SHIPPING DEVICE The present invention relates to a novel device and method for intradermal delivery of an active agent. The device comprises a housing containing a reservoir chamber. A flexible reservoir containing the active agent is disposed in the chamber. With pressure on a trigger the active agents are sent through a hollow needle to the skin.

Description

Descriptive Report of the Invention Patent for "DRUG POSITIVE".

Field of the Invention

The present invention relates to drug delivery devices and methods of delivering a drug intradermally. In particular, the present invention relates to the intradermal delivery of a liquid drug.

Background of the Invention

There has long been a desire to administer drugs intradermally. The skin comprises two layers, the outer or upper surface called the epidermis, and the inner surface referred to as the dermis. The epidermis does not contain any blood vessels and is dependent on the underlying dermis for nutrient delivery and waste disposal through diffusion. The inner layer, the dermis, is composed of two layers, the most superficial papillary dermis and the deepest reticular dermis. The papillary dermis is thinner and consists primarily of loose connective tissue containing small capillaries, elastic fibers, reticular fibers and some collagen. The deepest reticular dermis consists of a thicker connective tissue that contains larger blood vessels, intertwined elastic fibers, and core axes of collagen fibers arranged in layers parallel to the surface. The reticular layer also contains many antigen cells, fibroblasts, mast cells, nerve terminals, and lymphatic cells. The deepest reticular dermis is formed by a thick connective tissue with wider blood vessels, intertwined elastic fibers, and collagen fiber core fiber bundles arranged in layers parallel to the surface. The reticular layer also contains many antigen presenting cells, fibroblasts, mast cells, nerve endings, and lymphatic cells. Because of the large amount of blood vessels, lymphatic cells, and antigen presenting cells in a dermis, this is the ideal site for the administration of drug / antigen.

A major problem, however, with intradermal administration is the difficulty of precisely administering the drug to the dermal layer. Generally, the outer layer, the epidermis, has a thickness of approximately 0.05 mm to 2 mm and the dermis has a thickness of approximately 1.5 mm to 4 mm. Thus, to deliver a dermis agent, the needle must penetrate the skin to a depth of no more than 5 mm, preferably between approximately 2 mm and 4 mm. It is very difficult to control an injection at this shallow depth. For certain types of injection, such as the Mantoux tuberculosis test, a small needle is inserted at a 45 ° angle to try to make the agent reach the dermis.

Several efforts have been made to try to find reliable ways to administer agents for the dermis. For example, US Patent Application No. 2005/0124967 is directed to a method for directly administering a high molecular weight substance into the intradermal space within the mammalian skin comprising administering the substance through at least one hollow needle being provided. from an outlet with an exposed height between 0 and 1 mm, said outlet being inserted into the skin to a depth of between 0.3 mm and 2 mm, so that a substance administration occurs at a depth of between 0.3 mm and 2 mm and a microneedle for intradermal injection of a high molecular weight pharmaceutical substance, in which the microneedle is provided with a selected length and outlet to suit the specific administration of a dermis substance.

US Patent No. 5,527,288 describes an intradermal drug delivery device for administering a liquid drug to a cocoon through the guinea pig skin, comprising a compartment provided with a lower surface for application to a guinea pig skin; means for securing the housing in position with the bottom surface in contact with the guinea pig's skin; and a drug reservoir inside the compartment. The reservoir is in the form of a retractable and expandable chamber which is expanded when filled with the drug and which can be contracted to release the drug from there. A single hollow needle is associated with the drug reservoir and extends across the lower surface and is provided with an internal termination in communication with the drug reservoir and an external termination projecting outward at a sufficient distance from the drug reservoir. So as to penetrate through the epidermis and into the dermis the compartment is pressed against the skin. The device also includes means for actively discharging drug from the reservoir to the guinea pig through the needle.

U.S. Patent No. 6,689,118 is directed to a method of making an intradermal injection into an animal's skin for systemic administration or to induce an immune response. The method comprises providing a drug delivery device including a needle cannula having a front needle tip and a needle cannula in fluid communication with a substance contained in said drug delivery device; inserting the needle tip into an animal's skin and securing the surface of a skin with a skin-holding surface of a limiting portion that securing the skin of the limiting portion limits the needle tip penetration within the dermis layer of a doanimal skin; and expelling the substance from the drug delivery device through the needle tip into an animal skin to expose the injected substance to the microcirculatory blood vasculature and the lymphatic plexuses.

U.S. Patent No. 6,569,143 is directed to another method of applying an intradermal injection comprising providing a drug delivery device; inserting the needle tip into an animal skin whereby penetration of the needle tip is limited to the dermis layer of an animal skin; and expelling the substance of said drug delivery device through the needle tip into an animal skin.

U.S. Patent No. 5,997,501 describes an intradermal drug delivery device for administering at least one drug to a guinea pig through the guinea pig's skin. The device comprises a compartment having a lower surface; a drug reservoir located with the compartment; a liner that is secured to the housing with an adjustable housing from a first position extended to a second retracted position so that the housing is close to the bottom surface of the housing when the housing is retracted and the housing is distal to the bottom surface of the housing when the housing is retracted. coating is extended; means for affixing the deposition coating to the lower surface of the compartment in contact with the guinea pig skin; a single hollow needle attached to the sheath and provided with a first termination in communication with the drug reservoir and the second termination projecting no more than the lower surface of the compartment when the sheath is extended, and to penetrate through the epidermis and inside the dermis when the lining is retracted; and means for actively discharging the drug from the reservoir to the guinea pig's skin through the needle.

Although multiple efforts have been employed to attempt to provide a device for intradermal administration, many of the above method devices are too expensive to produce or can be used for only one drug. Despite all efforts made to provide a method and / or device for intradermal administration, there remains a need for a disposable, reliable single use device for intradermal administration.

Summary of the Invention

Many people find that an injection is (at best) unpleasant and (at worst) a painful encounter, no matter how well the nurse or doctor administers the bite. This is because most injections are given subcutaneously or are intramuscular, reaching deep into a skin and reaching nerves. Part of the function of a skin is to warn of dangers in the environment through nerve cells, and it is richly endowed with such cells - a single square inch of skin contains approximately 1,300 nerve endings.

Since most injections are given subcutaneously or are intramuscularly, thus administering drugs to be absorbed into the blood vessels, the needle usually reaches nerves and causes it to travel along the way. The device of the present invention is based on a unique technology that allows a liquid pharmaceutical formulation to be delivered to a patient's skin through a fine, non-significant needle experienced by the use of regular injection needles. Drugs are injected into the layers of a skin, preventing puncture of the nerves. The aforementioned reduces the pain significantly or completely eliminates it in some cases thereby improving acceptance and compliance to treat many diseases such as diabetes.

The present invention addresses the problem of the above method by providing a novel type of drug reservoir and an administration device for administering the drug from the reservoir to a specific depth of skin. A method of preparing the drug reservoir and a method of administering a fluid drug is also provided.

In one aspect of the present invention a reservoir for carrying an active agent is provided. The reservoir comprises a fillable balloon with flexible walls which can be sealed.

A method of producing said reservoir is also provided. In one embodiment, the method comprises the steps of: opposing two layers of thermoplastic film; warm the movie; apply a vacuum mold to the outer surface of the film layer to form a bubble; and allow the film to cool.

In another embodiment, the method comprises preparing a sheet of thermoplastic material being provided with a series of fillable grooves or depressions as reservoirs. A top sheet is then applied to seal the reservoirs.

A method of filling the reservoir is also provided and comprises filling the balloon with a fluid drug; and seal the thorium reserve.

In another aspect of the present invention, a device for administering a fluid drug to an animal is provided. The term "animal" is used herein to include both humans and nonhuman animals. The devices and methods of the invention are applicable for both human and veterinary use. The device comprises a housing having an upper termination and a lower termination, the lower termination being provided with an opening itself and upper grounding being adapted to receive a drive drive. A reservoir function chamber is disposed inside the room and operatively connected to the drive drive. The reservoir function chamber is provided with a base and wall (s). The wall may be a continuous circular wall or a set of connected walls. Inside the chamber with reservoir function, there is a flexible reservoir filled with the fluid drug. The microneedle is mounted to the base so that it passes through the base of the chamber so that the top of the needle is in communication with the chamber and the needle tip extends through the compartment below the chamber.

In a preferred embodiment, the reservoir function chamber is located at a predetermined distance from the lower compartment termination whereby the chamber base boundary to the lower compartment termination acts as a stop to provide a predetermined needle travel length. through opening when the driving mechanism or actuator is activated. The displacement length is favorably adjusted to administer the drug intradermally. The device also preferably includes inclining means for keeping the reservoir function chamber upright within the housing in the absence of pressure on the actuator thereby retaining the needle tip within the housing.

In another embodiment of the invention, the device includes a lower compartment and an upper compartment that fits over the lower compartment. In said embodiment, the upper housing is continuous with the actuator, which causes the reservoir to descend and come into contact with the needle termination.

In yet another aspect of the invention, a method of administering a fluid drug through the skin of an animal is provided. The method comprises providing a device as defined above; apply the bottom surface of the device to a skin; exerting pressure on the driving mechanism thereby lowering the chamber with a reservoir function and causing the needle tip to move through the aperture and into a skin at a predetermined distance; and applying continuous pressure to the actuator to cause the upper needle termination to puncture the reservoir and continue to apply pressure so that the entire reservoir contents flow through the needle into the skin.

Said summary of the present invention need not necessarily describe all features of the invention.

Brief Description of Illustrations

Said and other features of the invention will become more apparent from the following description, in which reference is made to the accompanying illustrations, in which:

Figures 1A-1G illustrate the steps in manufacturing a drug reservoir according to the present invention;

Figures 2A to 2J illustrate the operation of one embodiment of a delivery device of the invention;

Figures 3A and 3B illustrate another embodiment of a delivery device; and

Figures 4A-4C illustrate yet another embodiment of an administration device.

Detailed Description

The following description is of preferred embodiments.

In one aspect of the present invention a new type of drug reservoir is provided. The drug reservoir comprises a fillable balloon. The reservoir is formed between two layers of plastic film. The two layers may be formed from two sheets or from a sheet folded in half. When two sheets are used, the sheets may comprise the same material, thickness, etc. or they may be two different types of sheets. The present invention provides a drug delivery device incorporating a disposable reservoir. The device may be provided as a single use, disposable device, or multipurpose device. The device comprises a housing which is provided with an upper termination and a lower termination. As used herein, the term "upper" is used to refer to the furthest surface from an individual skin and the term "lower" is used to refer to the part of the device that contacts a patient's skin. A trigger is mounted on top of the housing. The trigger is used to activate a driving mechanism. An example of a driving mechanism is a piston that moves up and down and inside the housing. A reservoir function chamber is slidably mounted inside the housing. The reservoir function chamber encloses a reservoir filled with a liquid. The chamber with reservoir function is operationally connected to the driving mechanism. The reservoir function chamber is provided with a microneedle mounted on a lower surface of the chamber. When the plunger is compressed, the reservoir housing moves downward into the housing until it stops when the bottom of the reservoir housing reaches the bottom of the outer housing.

A process for producing a reservoir embodiment is shown in FIGS. 1A-G. In Figure 1A, a sheet of thermoplastic material 10 is folded in half to provide a first surface 12 and a second surface 14. Referring to Figure 1B, sheet 10 is folded so that the first surface and the second surface overlap. put each other on. Then the foil is heated to soften the film. Figure 1C illustrates a mold 18 applied to each of the surfaces 12, 14. The mold for each side may be of similar or different shapes. As the vacuum is being applied to the mold halves, a bubble 20 is formed and at the same time the rim 22 of the reservoir shape is sealed. A vertical path 24 is kept open to fill the reservoir. As shown in Figure 1D, the mold halves 18 are removed and the sheet 10 including bubbles 20 is cooled to room temperature. The filling process is shown in figure 1 Ε. The film is preferably oriented with the vertical opening path 24 at the top to fill to prevent air pockets during the filling process. A thin dispensing nozzle 26 is inserted into the vertical path 24 and a controlled amount of drug 27 is inserted into the reservoir. The termination of the opening 30 of the vertical path 24 is then heat sealed as shown in Figure 1F. The bubble reservoir 20 may then be trimmed as shown in Figure 1G from the remaining sheets of plastic film or the bubbles may be partially trimmed and the bubbles may be stored in roll form.

In another embodiment, the reservoir is formed by preparing a sheet of material provided with a series of grooves or depressions. The grooves are filled with a drug and then an upper sheet is applied to the coating and seals the upper groove opening. In both embodiments, the reservoir comprises a fillable, sealed balloon of thermoplastic material.

Various reservoir colors and shapes can be used for different drugs. For example, a blue round blister may indicate that the reservoir contains insulin and a pink square blister may indicate an OPT vaccine. The reservoir of the present invention may be used to store many different types of active agents. Color codes can be used to identify the agent and / or dose strength.

The present invention also provides a device and method for administering the drug stored in the reservoir to an animal, preferably a human. The device comprises an external compartment. The outer housing can be made of any durable material, preferably a rigid plastic. The outer compartment can assume various shapes, for example it can be round, oval, hexagonal, square, etc. The outer housing may incorporate various colors to identify the agent and / or dose strength. The outer housing defines an inner chamber which includes an open top at the upper termination and a base having an opening at the lower termination. A camera with reservoir function is secured inside the compartment. The reservoir function chamber is adapted to receive a disposable reservoir such as those described above. A microneedle is mounted on the underside of the reservoir function chamber platform with its upper extremity, the termination pointing up and just below the reservoir and the skin contraction tip extending beyond the underside of the reservoir. chamber. The chamber with reservoir function frictionally grips the inner walls of the compartment. A drug reservoir or blister is contained within the reservoir function chamber.

A drive actuator is operatively connected to a chamber with reservoir function. The motion drive may include a flexible cover or an upper guard. The reservoir function chamber typically comprises an open upper termination, an inner chamber for holding the reservoir, and a base platform with the needle mounted so that it pierces the base. A retraction mechanism, such as a vacuum tube or a spring, is also optionally included.

When in use, the delivery device is placed in it with the lower end of the compartment touching the skin. The driving mechanism is then activated to drive the reservoir function chamber down until a reservoir function base platform reaches the base of the compartment. The foregoing causes the needle to exit through the opening in the base of the compartment at a predetermined distance and penetrate a skin at a predetermined depth. Continued pressure on the plunger compresses the drug filled reservoir and causes it to be punctured by the upper end of the needle. Said places the needle cannula in fluid communication with the reservoir content and while the downward pressure continues until the piston tip reaches the base of a camera base platform with reservoir function, the reservoir contents are passed through the needle cannula to a skin of an animal or human subject. When the pressure in the conduction mechanism is relaxed, the retracting means causes the needle to be retracted back into the spinal compartment.

A preferred embodiment of the device and its operation are shown in figures 2A-J. Device 50 comprises a housing52. The housing is provided with an open upper end 54 and a lower base 56 defining an inner chamber 58 which optionally includes a spring. The underside of the base comprises an opening 60. The interior of the housing is adapted to receive a reservoir function chamber 62. The reservoir function chamber comprises base 64 and the surrounding wall 66 extending upwardly from the base defining chamber 62 with an open top 68. The filled reservoir body 70 is located in the reservoir function chamber.

A single hollow needle 72 is associated with the reservoir function chamber 62. The needle 72 extends through the base 64 of the chamber62 and is provided with a cannula with an upper end 74 in communication with the interior 75 of the chamber with reservoir function and a lower termination 78 projecting out of the chamber and below the predetermined distance. The open end 68 of the reservoir chamber is adapted to receive an actuator 80. In the illustrated embodiment, the actuator comprises a plunger 82 having an activation edge 84 on one end and a lock 86 on the other end. In the initial position of the device as provided and as shown in Figures 2A and 2B, the base 64 of the reservoir function chamber 62 is secured at a predetermined distance from the interior surface 88 of the base 56 of the compartment by at least one removable lock 90 a. which holds the camera in position by the interaction of lock 90 with lock retainer 92. Lock 90 includes notch 91.

In a preferred embodiment, an upper housing 96 closes the piston 80.

It is clearly apparent that the distance by which the locating needle may vary depending upon the desired application and the position of the needle and the length of the needle. For example, the device may be adapted to be provided with a needle displacement with a distance of from about 0.5 mm to about 10 mm. Accordingly, the device of the invention may be adapted for intradermal, subcutaneous or intramuscular injections. The needle preferably moves from about 3 mm to 8 mm. The needle gauge is preferably 25 to 84 although different needle gauges may be used.

The operation of the device is illustrated sequentially in Figures 2A to 2J. Figures 2A and 2B illustrate the device in its initial state as described above. Referring now to Figures 2C and 20 parause, housing base 56 is placed against the skin. When pressure is exerted on driver 80, latch 90 is released from retainer92. The driver 80 is connected with the reservoir function chamber 62 via the notch 100 and the tab connector 102 and the reservoir function chamber will be forced downward, the base 64 of the reservoir function chamber 62 reaches the inner surface 88 of the base compartment 56 and the chamber is stopped from any subsequent downward movement. By adjusting the relative sizes and positions of the components, the length of needle displacement through the opening in a skin can be firmly controlled. The distance at which the needle extends is approximately 0.5 mm to 10 mm, preferably 0.5 mm to 5 mm, more preferably from approximately 3 mm to approximately 5 mm, and most preferably. from approximately 1.5mm to 3mm. The outer layer of skin, the epidermis typically has a thickness of approximately 0.5 mm to 2 mm and the inner layer, dermal, is provided with a thickness of approximately 1.5 mm to 3 mm. Adherm comprises two layers, the papillary layer and the reticular layer. The reticular layer contains many blood vessels and lymphatic vessels, making it a desirable area for the administration of active agents. Lower dermis is the subcutaneous layer and then muscle. In a preferred embodiment, the distance the needle tip has to extend beyond the outer surface of the compartment is selected to be suitable for insertion into a dermis or subcutaneous layer. While the reservoir function chamber 62 carries needle 72 downward, the lower needle tip 78 leaves aperture 60. The downward movement of the reservoir function chamber 62 is limited when the base 64 of the chamber contacts base 56 of the housing. Thus, the displacement of the needle through aperture 60 is also limited to limit the depth of penetration of the needle into a skin. The device components have been configured such that the distance the lower part of the chamber travels translates to a predetermined needle displacement through the opening in the lower part of the compartment to provide some penetration into the skin.

Referring now to Figures 2E and 2F, while continuous pressure is applied to the driver 80, the flap 102 is released from the notch 100 and the piston 82 descends into the reservoir chamber forcing the filled reservoir 70 down to said contact the base 64 of the reservoir chamber 62. While the actuator 80 exerts pressure on the reservoir 70, the reservoir 70 contacts the upper end 74 of the needle 72 and is punctured. Needle cannula 72 is now in fluid communication with the reservoir contents.

Referring now to Figures 2G and 2H, the continuous pressure on driver 80 compresses reservoir 70 and forces all contents to flow through needle 72 to the patient. The downward movement of the donor 80 is interrupted when the piston lock 86 contacts the base 64 of the reservoir chamber 62.

After use, the needle is preferably retracted back into housing 52 as shown in Figures 21 and 2J. The position of the reservoir function chamber 62 carrying the needle 72 is preferably inclined to the pre-activation position by tilting the means such as a spring, a vacuum tube or a moldable tube. Once the pressure is released on driver 80, the base 64 of the reservoir chamber moves upwards in the housing, thereby automatically retracting the used needle into the housing. The aforesaid provides the safe disposal of the device. In the preferred embodiment, the needle is preferably locked in the retractable position. Figure 2J shows a chamber with retracted reservoir function that is locked in position when the tab 102 slides into the notch 104.

In the embodiment illustrated in FIGS. 3A and 38, a driver 106 is continuous with an upper guard 108 which fits over an enclosure 110. The housing 110 receives a reservoir function chamber 112 which is provided with a transversely mounted needle 114 through through its base 116. A drug reservoir 118 is contained in the inner chamber 112. As shown in Figure 38, the pressure in the actuator 106 causes the reservoir function chamber 112 to drop to the base120 of compartment 110. While the chamber 112 descends, guides needle 122 122 through an opening 124 in housing 110. A back pressure causes the back 126 of the needle to pierce the reservoir 118. As pressure continues, the contents of the reservoir are expelled. -do through the needle.

In another embodiment, a flexible cover fits over the piston skirt and the activation edge. It is also clearly apparent that the manual activation board can be exposed. The device also optionally includes a spring that is located around or below the reservoir chamber base so that when pressure at the activation edge is released, the compressive energy of the spring causes the agulhase to retract back into the chamber. compartment.

Figures 4A-4C illustrate another embodiment of the device. Device 130 includes a housing 132 and an upper guard 134. A humidifier 136 is operatively connected to a reservoir function chamber 138 disposed within compartment 132. For use, drug-filled reservoir 140 is placed in the reservoir function chamber. 138. The needle 142 is mounted to pass through the base144 of the chamber 138. The device also includes a spring 146 which tilts the reservoir chamber 138 upwards in the compartment 132. Under pressure of the nozzle 136, the spring compresses and the reservoir function chamber sedesloca down carrying the needle and the needle tip 148 to the compartment 132. Under further pressure, the driver 136 compresses reservoir 140 until the needle return 150 pierces the reservoir and the content flows through the needle as shown in the figure. 4C.

In another aspect of the invention, a method for administering an effective amount of an active agent liquid to an animal, preferably a human, is provided. The method comprises providing a drug delivery device according to the present invention, said device containing a reservoir filled with the desired drug; apply undersurface of the drug delivery device of the invention to an animal's skin, apply pressure to the trigger to cause the needle to penetrate the skin, apply continuous pressure to puncture the reservoir and deliver the reservoir contents through the cannula Needle

The device of the present invention may be used to administer a variety of active agents. The term "drug" is used loosely herein to refer to prophylactic as well as therapeutic agents. For example, vaccines may be administered using the device. In addition, the term broadly refers to active agents such as nucleic acids, small molecules, proteins, hormones, pain killers, etc. therapeutic agents in addition to traditional pharmacological agents. Typical drugs include peptides, proteins or hormones such as insulin, calcitonin, atrial calcitonin-regulating protein natri-retic protein, colony stimulating factor, betaseton, erythropoietin (EPO), interferons such as Vinterferon, somatropin, somatotropin, somatostatin, insulin-like growth (somatomedins), Iuteinizing hormone-releasing hormone (LHRH), tissue plasminogen activator (TPA) 1-growth hormone-releasing hormone (GHRH), oxytocin, estradiol, growth hormones, leuprolide acetate, factor VIII, interleukins such as interleukin-2, and analogs thereof; analgesics such as fentanyl, sufentanyl, butorphanol, buprenorphine, levorphanol, morphine, hydromorphone, hydro-codone, oxymorephone, methadone, lidocaine, bupivacaine, diclofenac, napro-xen, pavefin, and the like; anti-warming agents such as nostriptriptan, ergot alkaloids, and the like, anticoagulant agents such as hepafine, hirudin, and the like; anti-mimetic agents such as scopolamine, ondansetron, domperidone, metoclopramide, and the like; cardiovascular agents, antihypertensive agents and vasodilators such as diltiazem, clonidine, nifedipine, verapa-mil, isosorbide-5-mononitrate, organic nitrates, agents used in the treatment of cardiac disorders, and the like; sedatives such as benzodiazepines, phenothiozines, and the like; narcotic antagonists such as naltrexone, naloxone, and the like; chelating agents such as deferoxamine, and the like; antidiuretic agents such as desmopressin, vasopressin, and the like, antineoplastics such as 5-fluorouracil, bleomycin, and the like; prostaglandins and the like; and chemotherapeutic agents such as vincristine, and the like. Stabilized drug preparations that can be stored at room temperature are particularly preferred for use in the device and method.

The term "fluid" refers to any fluid that contains an active agent or agent communication that may pass through the dome-needle cannula. Said includes a liquid, a solution, a gel, a dispersion or a thin suspension.

All quotations are incorporated herein by reference.

The present invention has been described with attention to one or more embodiments. However, it will be clear to those skilled in the method that a number of variations and modifications may be made without prejudice to the scope of the invention as defined in the claims.

Claims (32)

1. Reservoir for carrying an active agent, said reservoir comprising a bladder capable of being filled with thermoplastic material. Reservoir according to claim 1, wherein the reservoir has a color coding for a specific drug. Reservoir according to claim 1, wherein the bladder has a capacity of 0.2 ml to 10 ml. Reservoir according to claim 3, wherein the bladder has a capacity of 0.3 ml to 6 ml. Reservoir according to claim 4, wherein the bladder has a capacity of 0.5 ml to 3 ml. Method of manufacturing a reservoir as defined in claim 1, comprising the steps of: i. providing at least one sheet provided with a pressure formed therein and providing said one with a second sheet. The method of claim 6 further comprising the steps of: i. fill the blister with the drug fluid; hey. seal the bubble. A device for sending a fluid drug to an animal, said device comprising: i. a housing provided with an upper end and a lower end, said lower end having an opening thereof and said upper end being associated with a driver; a reservoir chamber disposed within the housing and operably connected to the actuator, said reservoir chamber comprising a base and wall (s) iii. a flexible reservoir filled with fluid drug disposed within the reservoir chamber; eiv. a needle mounted to traverse the base of said chamber so that the back of the needle is in communication with the chamber and the needle tip extends into the housing below the chamber. Device according to claim 8, wherein the reservoir chamber is located at a predetermined distance from the lower end of the housing wherein the bottom of the chamber touch to the lower end of the housing acts as a stop. to provide a predetermined needle path length through the opening when the actuator is activated. The device of claim 9, wherein the length of the needle path is from about 0.5 mm to about 10 mm. The device of claim 9, wherein the needle path length is from about 1.5 mm to about 8 mm. The device of claim 9, wherein the length of the needle path is from about 3 mm to about 8 mm. The device of claim 8, wherein the actuator is a piston comprising a plunger rod having an activating edge at one end and a stop at the other end. The device of claim 8, further comprising guiding means for retaining the needle with housing in the absence of pressure in the drive mechanism. Device according to claim 14, wherein the actuation method comprises an air bladder. Device according to claim 14, wherein the drive means comprises a spring. Device according to claim 16, wherein the mold is arranged below the base of the reservoir chamber. Device according to claim 16, wherein the hand is associated with the actuator. The device of claim 8, further including a pierceable septum covering said aperture. A method of administering a fluid drug through the skin of an animal, said method comprising: i. providing a device as defined in claim 8. ii. apply the bottom surface of the device to the skin iii. exerting pressure on the actuating member thereof by reducing the reservoir chamber and causing the needle tip to flow through the opening and into the skin at a predetermined distance; eiv. apply continuous pressure to the drive member to cause the upper end of the needle to puncture the reservoir and reservoir contents to flow through the needle into the skin. A method according to claim 20, wherein the sharp needle is limited to travel a depth of 1.5 mm to 8 mm. The method of claim 20, wherein the sharp needle is limited to travel a depth of 1.5 mm to 3 mm. The method of claim 20, wherein the sharp needle is limited to travel a depth of 3 mm to 5 mm. The method of claim 20, wherein the prick needle is limited to travel a depth of 5 mm to 8 mm. The method of claim 20, further comprising the step of retracting the needle back into the housing after use. The method of claim 25, wherein the retracting step is implemented by the guide means automatically relieving pressure on the drive member. A device for delivering an active agent to the skin, said device comprising: i. an accommodation ii. a reservoir chamber releasably positioned in said housing, said reservoir chamber adapted to receive a reservoir containing an active agent iii. at least one needle provided with an upper opening and a lower opening defining a cannula passing through the base of the reservoir chamber; eiv. drive means for moving said chamber downwardly within said housing. The device of claim 27, wherein said reservoir chamber further comprises locking means for retaining said chamber in an upward position in the housing, said locking means adapted to release with a downward pressure actuator . The device of claim 28, wherein said locking means includes a tab and a bevel for connection to the plunger. The device of claim 29, wherein said drive includes at least one chamfer for receiving said tab locking means. The device of claim 29, wherein said driver comprises an upper chamfer and a lower chamfer. The device of claim 29, wherein said upper chamfer receives said tab for locking said needle in a retracted position.